Effect of Caudal Nalbuphine on Postoperative Analgesia in... | NCT02618876

Studies
Effect of Caudal Nalbuphine on Postoperative Analgesia in Children

NCT02618876

Sponsor

Assiut University

Status

Completed

Last Update Posted

Apr 7, 2020Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

Nalbuphine plus Bupivacaine
Bupivacaine

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Dec 2019Actual

Completion Date

Dec 2019Actual

First Submitted Date

Nov 25, 2015

First Submission Date that Met QC Criteria

Nov 29, 2015

First Posted Date

Dec 2, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2020

Last Update Posted Date

Apr 7, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Nalbuphine as an adjuvant to bupivacaine caudal anesthesia for postoperative analgesia in children undergoing Hypospadias repair.

2 groups, 30 patients each

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nalbuphine group	Active Comparator	30 children will be given Caudal Bupivacaine plus Nalbuphine.	Drug: Nalbuphine plus Bupivacaine
Control group	Other	30 children will be given Caudal Bupivacaine.	Drug: Bupivacaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nalbuphine plus Bupivacaine	Drug	Addition of caudal Nalbuphine to the standard Bupivacaine	Nalbuphine group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative pain intensity Measured by Face, Legs, Activity, Cry & consolability (FLACC) pain scale		During 24 h in the postoperative period

Secondary Outcomes

Measure	Description	Time Frame
Cortisol level		6 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children undergoing elective Hypospadias repair
with American Society of Anesthesiologists (ASA) physical status I
age 2-10 years

Exclusion Criteria:

Coagulation disorder
allergy to study medications
major malformations of the lower spine or meninges or any cutaneous or subcutaneous lesion at the site of injection.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University Hospital		Asyut		71515	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009266	Nalbuphine
D002045	Bupivacaine

Ancestor Terms

ID	Term
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided